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The HALLU® PLATES are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metastarso-phalangeal joint, including cases of.

• Hallux rigidus .
• Severe hallux valgus (IM angle >20° and HV angle >40° ) .
• . Deformity from rheumatoid arthritis
• Failed previous surgical procedure .
• Traumatic arthritis .
• Neuromuscular instability .

Addition of a screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.

The Newdeal HALLU® PLATES is a low profile Titanium plate dedicated to first metatarsophalangeal arthrodesis. The system includes both HALLU" -FIX C plates as well as HALLU -FIX S plates. The plates are used in conjunction with Newdeal SNAP-OFF® screws.

The provided document describes a Special 510(k) Summary for a medical device called "Modified Newdeal HALLU® PLATES." This type of submission is for modifications to a device already cleared by the FDA, relying on the substantial equivalence principle rather than extensive clinical efficacy studies.

Therefore, the "study" conducted is a mechanical equivalence test rather than a typical clinical study proving performance against acceptance criteria in a human population.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not specified. The document states "Mechanical tests have been carried out," but does not detail the number of plates tested or the specifics of the test setup (e.g., number of cycles, loads applied).
• Data Provenance: The tests were conducted by the manufacturer, Newdeal SAS, which is located in France. The data is thus prospective test data generated to support the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

• This question is not applicable in this context. For mechanical equivalence testing, the "ground truth" is defined by established engineering and biomechanical principles and standards used to compare the mechanical properties of the modified device to its predicates. There are no "experts" establishing ground truth in the sense of clinical interpretation or diagnosis.

4. Adjudication Method for the Test Set

• This question is not applicable. Mechanical tests are typically analyzed objectively based on sensor readings and engineering calculations, not through an adjudication process like those used in clinical image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• This question is not applicable. This device is a bone fixation plate, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• This question is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is established through objective mechanical testing against the known mechanical properties of the legally marketed predicate devices. This involves comparing engineering parameters such as strength, fatigue resistance, and stiffness, as relevant to the device's function.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" as this is not an AI/ML device. The "training" for such a device would be the design and manufacturing processes guided by engineering principles.

9. How the Ground Truth for the Training Set was Established

• This question is not applicable for the same reason as above.

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The B-BOP® plate is intended for fixation of osteotomy of the basis of the first metatarsal. Examples include:

• Moderate to severe hallux valgus
• Hallux varus

Newdeal has developed a plate dedicated to the fixation of basal osteotomy of the 1st metatarsal by designing the B-BOP® plate which allow to meet at best the specifications of that kind of surgical procedure.

Characteristics of the plate have taken into account all the requirements associated with basal osteotomy:

• Plantar positioning to obtain the best stability and resistance and allowing to reduce bulk
• Anatomical shape adapted to the plantar curve of the 1st metatarsal (pre-bent), available in right or left side and in two angulations (5° and 10°) for medium or large deformation.

The B-BOP® plate is made from titanium alloy (Ti-6AI-4V ELI) and the part of the plate in contact with bone is sandblasted for a better adherence of the plate.

Plates and screws are also available which are color-coded for ease of identification.

Fixation of the plate is provided by four Snap-Off screws, already present with the HALL 0 -Fix system (cleared under K021626).

With the B-BOP® plate, screws are available in 2 diameters (2.7mm and 3.0mm) and in a length range from 14mm to 26mm (2 mm increment). The screws are provided sterile with the B-BOP® plate.

Here's an analysis of the provided text regarding the acceptance criteria and study for the B-BOP® plate, structured according to your request.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not specify the sample size used for the test set for either the bending strength or fatigue testing.
The data provenance (e.g., country of origin, retrospective/prospective) is also not specified for these tests. It can be inferred that the testing was conducted by or on behalf of Newdeal SAS, a French company, but the specific location of the testing is not stated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This document describes mechanical testing (bending strength and fatigue testing) of a medical device (B-BOP® plate). Mechanical testing does not typically involve human experts to establish ground truth in the same way clinical studies or diagnostic AI algorithms do. Instead, performance is measured against engineering specifications and industry standards. Therefore, this section is not applicable to the type of study described.

4. Adjudication Method for the Test Set

As the study involves mechanical testing and not human interpretation or clinical outcomes, an adjudication method in the sense of expert consensus for ground truth is not applicable. The "adjudication" is inherent in the measurement and comparison against predefined engineering acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This document describes mechanical testing of a medical implant and does not involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not Applicable. This document details the mechanical testing of a physical medical device (a plate), not a software algorithm or AI.

7. The Type of Ground Truth Used

The ground truth for this study appears to be predetermined engineering specifications and industry standards for bending strength and fatigue life of bone fixation plates. The document states, "The B-BOP® plate meets our acceptance criteria," implying that these criteria (standards for mechanical performance) served as the "ground truth."

8. The Sample Size for the Training Set

Not Applicable. This document describes mechanical testing of a physical device. There is no "training set" in the context of an AI algorithm or statistical model.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set, the method of establishing its ground truth is irrelevant.

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